aqis biological imports program microalgae questionaire

The importer and manufacturer (of both the microalgae and the finished product if different) are to complete (in English) and submit the relevant sections of this questionnaire for each product containing microalgae. The responses to this questionnaire may be forwarded to Biosecurity Australia for review.

Over the course of 2008 AQIS became aware of a number of practices undertaken in the cultivation and production of microalgae for human and animal use that may result in products being potentially contaminated with exotic animal disease agents. The animal quarantine risks associated with these practices are significant if the product is consumed (intentionally or unintentionally) by aquatic or terrestrial animals. This discovery has necessitated an increase in the level of detail provided with applications to import microalgae products in order for AQIS to fully assess the quarantine risks.

This questionnaire has been introduced as part of this process. It will be used for high risk products such as stockfeed, stockfeed supplements (including oral veterinary therapeutics for livestock) and bulk aquaculture feed. This questionnaire may also be required for other animal foods where there is potential for diversion of products for these uses or where there is a high likelihood of contamination of the product with exotic disease agents and the product is intended for use in potentially susceptible animals.

Animal feeds are high quarantine risk products as they provide a direct pathway or vehicle for the exposure of susceptible animals in Australia to exotic disease agents. Because microalgae production is undertaken under a wide range of conditions, the quarantine risk associated with products containing microalgae for use in animals (or products that could be diverted for use in animals) will depend on the specific circumstances for each individual application.

Each import application containing microalgae will be examined on a case by case basis. This questionnaire, along with other documentation, is intended to ensure that sufficient relevant information is provided to allow the quarantine risks to be fully assessed.

It is important to assess the animal quarantine risks associated with all aspects of the production process. This includes the starter culture, growth, production, processing, storage and transport of the microalgae and the production, processing, storage and transport of the final product.

This questionnaire will be used in conjunction with the “Questionnaire For Use With Imported Stockfeeds and Stockfeed Ingredient” as per “Importation of Stockfeed and Stockfeed Ingredients – Finalised Risk Management Measures for Transmissible Spongiform Encephalopathies (TSE) March 2003, where:

• the product is intended for use in Australia as stockfeed, stockfeed supplements (including oral veterinary therapeutics for livestock) and bulk aquaculture feed, or
  
• could be diverted for this use after importation, or
  
• there is a high likelihood of contamination of the product with exotic disease agents and the product is intended for use in potentially susceptible animals.

There may be duplication of the information provided in these questionnaires; however this will be taken into account during assessment of your application.

Please note that if the information provided in response to this questionnaire is incomplete, this may delay the processing of your application.

SECTION A (to be completed by Australian importer): 

1. AQIS Application reference number.

2. Previous import permit number/s (if applicable).

3. Quarantine Approved Premises details (if applicable) (include QC level).

4. End use (i.e. species, purpose e.g. food, therapeutic).

5. Name the microalgae species and if available, please attach information on presence/absence of the microalgae in Australia (e.g. database/literature references).

Importer’s declaration

I declare that the information provided above is true and accurate to the best of my knowledge.

Signature: ______________________ Position: ___________________Date: ___________

Printed name: ___________________

Company (including address and country): __________________________________________

SECTION B (to be completed by manufacturer of the microalgae): 

1. Country of origin/manufacture/processing of microalgae

a. Name and address of company producing the microalgae.

b. Address/location of site of production of microalgae (if same as above write as above).

c. Is the facility an establishment registered and inspected by the government?

d. If so, what is the standard under which the facility is registered?

e. Please provide details of the standard and confirmation that the facility is currently registered and has been inspected against that standard.

f. Is the facility registered and inspected by any other organisation other than the government?

g. If so, please provide details as above.

2. Taxonomically valid scientific name (genus and species required, strain if known) and common name of microalgae cultivar

3. Production of the Masterseed/Cultivar

a. What is the source of the microalgae isolate (culture collection or origin of isolate)?

b. Provide the name of the culture collection, or describe the method of isolation and culture, and where the seed for new batches is obtained.

c. Provide details of all the ingredients used in the culture media used (include % of each ingredient adding up to 100%)

d. Are any culture media ingredients derived from animals or animal products?

4. Cultivation/Growth System

a. Are any of the ingredients/culture media/nutrients/fertilizer such as animal manure, effluent from animal production (including from aquaculture) used in the cultivation/growth system derived from animals or animal products?

b. Provide a full list of ingredients of all fertilisers, culture media and nutrients used during each stage of cultivation/growth (include % of each ingredient adding up to 100%).

c. Attach a copy of the product label or tag of the fertilisers, culture media and/or nutrients.

d. Provide a detailed description of the cultivation/growth system (i.e. open or closed culture system, outdoor or indoor ponds, raceways, covered or uncovered vats, or tanks), harvest and processing. Attach photographs and flowchart indicating the inputs, outputs and controls applied from the commencement of cultivation through to harvesting, processing and packaging.

e. What is the length of time that the microalgae batches are cultivated/grown, the temperature, pH and salinity of the growth environment?

f. Provide a detailed description of the water source used in cultivation/production, including origin of the water source, microbial analysis conducted and treatments applied (i.e. filtering, sterilisation, testing process).

g. Are there any live animals (including domestic, wild and native) present on, or with access to the cultivation/growth facility?

h. If yes please list.

i. If no, please describe how access by live animals is prevented (Attach photographs where possible).

j. What other products does the establishment process and/or cultivate?

k. If products are other microalgae species, what are these species?

l. Do any of these products contain or are grown or manufactured using organic fertilisers, manure or animal material?

m. If so please provide details.

5. Processing

a. Provide full processing details including treatments and/or inactivation method applied to the microalgae (e.g. flow chart, times and core temperatures, autoclave, moist or dry heat etc.).

b. Describe how and under what conditions the microalgae are held between harvesting and processing?

c. Is the microalgae product tested for purity (including culture purity, microbiological, viral or other contamination)?

d. If so, please detail the testing regime.

e. Are test results available for recent batches of microalgae?

f. If so, please attach.

g. If not, please explain why these are not available.

h. Are there any live animals (includes vermin such as birds, rodents etc) present on, or with access to the processing and storage facilities or areas?

i. If yes please provide details.

j. If no, please describe how access by live animals is prevented (Attach photographs where possible).

6. Transport/containment/packaging

a. Describe the method of transport, storage/containment/packaging (e.g. individually packaged units and their size/weight).

b. Please describe how the company prevents post-production contamination occurring from animals (includes vermin such as birds, rodents etc) and animal material.

c. Please provide a copy of the label for the product.

Manufacturer’s declaration

I declare that the information provided above is true and accurate to the best of my knowledge.

Signature: ______________________ Position: ___________________ Date: ___________

Printed name: ___________________

Company (including address and country): __________________________________________

SECTION C (to be completed by manufacturer of the final product): 

1. Country of origin/manufacture/processing of the final product containing microalgae

a. Name and address of company producing the final product containing microalgae.

b. Address/location of site of production of the final product containing microalgae (if same as above write as above).

c. Is the facility an establishment registered and inspected by the government?

d. If so, please provide details of the standard and confirmation that the facility is currently registered and has been inspected against that standard.

e. If the facility is registered and inspected by other organisations, please provide details as above.

2. Final product details including processing/packaging/transport and storage

a. Product name.

b. What animal species is the final product manufactured for?

c. What is the individual package volume/weight and form (i.e. powder, tablet/capsules, pellets, crumbles, kibbles, flakes) for the final product to be imported into Australia?

d. Please attach the full list of all ingredients (include % of each ingredient adding up to 100%).

e. Are any ingredients derived from animals or animal products?

f. Is the microalgae ingredient tested for purity (including culture purity, microbiological, viral or other contamination)?

g. Are test results available for recent batches of microalgae used in the final product to be imported into Australia?

h. If so, please attach.

i. If not, please explain why these are not available.

j. Provide full processing details identifying heat treatments and/or microbial inactivation processes applied to the final product. For treatments and inactivation steps, core temperatures, moist or dry heat, pressure and steam parameters, and length of times of treatments must be provided (a flow chart should be provided in addition to a written description).

k. What other products does the establishment/manufacturing plant/s process?

l. Do any of these products contain or are manufactured using animal material, organic fertilisers or manure?

m. Are there any live animals (includes vermin such as birds, rodents etc) present on, or with access to the manufacturing, processing, packaging, transport and storage facilities?

n. If yes please detail.

o. If no, please describe how access by live animals is prevented (Attach photographs where possible).

p. Describe the method of transport/containment/packaging (e.g. individually packaged units and their size/weight).

Manufacturer’s declaration

I declare that the information provided above is true and accurate to the best of my knowledge.

Signature: ______________________ Position: ___________________ Date: ___________

Printed name: ___________________

Company (including address and country): __________________________________________